Fig. 2

Patient disposition. *Dosage deviations were reported in 9 (2.5%), 11 (3.0%), 12 (3.2%), and 16 (4.5%) patients, in the IC43 100 μg with adjuvant, 100 μg without adjuvant, 200 μg with adjuvant, and placebo groups, respectively. Treatment assignment deviations were reported in 2 (0.6%), 5 (1.4%), 3 (0.8%), and 2 (0.6%) patients, respectively. †Early study terminations due to patient deaths, as documented in the case report form. In addition, a further patient from the group randomized to IC43 100 μg without adjuvant who died, and for whom the date and primary cause of death was missing, is not included in this figure. f/up follow up, ITT intention-to-treat, W/d withdrawn, w/o adj without aluminum hydroxide adjuvant, with adj with aluminum hydroxide adjuvant